A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy

NCT07588100 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BP46156
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Ocular Adverse Events (AEs)

  Up to Week 20

• Percentage of Participants With Systemic (non-ocular) AEs

  Up to Week 20

• Number of Abnormalities Recorded in Standard Ophthalmological Assessments

  Up to Week 20

Secondary Outcomes (2)

• Aqueous Humor (AH) Concentrations of RO7663498

  Up to Week 12

• Serum Concentrations of RO7663498

  Up to Week 20

Study Arms (4)

Cohort 1

EXPERIMENTAL

Participants will receive RO7663498.

Drug: RO7663498

Cohort 2

EXPERIMENTAL

Participants will receive RO7663498.

Drug: RO7663498

Cohort 3

EXPERIMENTAL

Participants will receive RO7663498.

Drug: RO7663498

Cohort 4

EXPERIMENTAL

Participants will receive RO7663498.

Drug: RO7663498

Interventions

RO7663498 DRUG

Participants will receive RO7663498 as per the schedule defined in the protocol.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and/or American Diabetes Association
• BCVA score at screening of \>= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
• Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)
• Collection of \>= 90 micro liter (μL) AH deemed feasible and safe by the investigator.

You may not qualify if:

• Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.
• History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.
• Center-involved Diabetic Macular Edema (DME)
• Any history or concurrent ocular conditions/procedures and/or visual system conditions of the below.
• Vitreoretinal surgery/pars plana vitrectomy.
• Any history of glaucoma surgery or planned glaucoma surgery during the study.
• Uncontrolled glaucoma
• Anterior segment neovascularization.
• Vitreous or preretinal hemorrhage.
• Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion.
• Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature \[SUN\] criteria \> 0 or National Eye Institute \[NEI\] vitreous haze grading \> 0) or any history of IOI.
• Aphakia or previous violation of the posterior capsule in the study eye
• BCVA \< 38 letters

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP46156 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share